A Phase 1 Study of FOR46 Administered Every 21 Days in Patients With Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Condition: Prostate Cancer Metastatic

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03575819

Sponsor: Fortis Therapeutics, Inc.

Phase: Phase 1


  • Age: minimum 18 Years maximum N/A
  • Gender: Male

Inclusion Criteria:

  • Male ≥ 18 years of age
  • Has histologically confirmed prostate cancer that is metastatic and has progressed as defined by PCWG3 criteria during or after treatment with at least 1 ASI (eg, abiraterone, enzalutamide, apalutamide), or another second-generation anti-androgen or cytochrome P450 (CYP)17A1 inhibitor, with the most recent ASI administered in the castration-resistant setting
  • Has serum testosterone levels < 50 ng/dL during screening. Patients without a history of bilateral orchiectomy are required to remain on luteinizing hormone-releasing hormone (LHRH) analog during the course of protocol therapy
  • ECOG performance status of 0 or 1
  • Adequate hematologic, renal and hepatic function
  • Males with female partners of childbearing potential must agree to use 2 effective methods of contraception
  • Patients must provide signed informed consent
  • Patients enrolled into the dose expansion phase must have prostate carcinoma without histologic evidence of small-cell/neuroendocrine carcinoma features on prior biopsy or must have unequivocal histologic evidence of small-cell/neuroendocrine prostate carcinoma (pure or mixed). Patients with treatment-emergent small-cell neuroendocrine cancer (pure or mixed) may have received no more than on prior chemotherapy regimen for mCRPC
  • Patients enrolled into the dose expansion phase must be willing to undergo a metastatic tumor biopsy or has tissue available from a prior post-castration resistant tumor biopsy

Exclusion Criteria:

  • Persistent clinically significant toxicities from previous anticancer therapy
  • Has NCI CTCAE Grade ≥ 2 peripheral neuropathy from any etiology or has a genetic disorder that is associated with peripheral neuropathy even without current neuropathic manifestations
  • Prior treatment with cytotoxic chemotherapy for mCRPC (chemotherapy in the hormone-sensitive setting is allowed if > 6 months before study entry)
  • Has received external-beam radiation or systemic anticancer therapy within 14 days before first dose of FOR46
  • Has received treatment with an investigational drug within 28 days before first dose of FOR46
  • Has had a major surgical procedure within 28 days before administration of FOR46 dose
  • Clinically significant cardiovascular disease
  • Uncontrolled, clinically significant pulmonary disease
  • Has a history of brain or leptomeningeal metastases.
  • Uncontrolled intercurrent illness
  • Has a known positive status for HIV or either active/chronic hepatitis B/C
  • Requires medications that are strong inhibitors or strong inducers of CYP3A4
  • [Dose escalation only] Has a history of episodic atrial fibrillation or flutter (patients with chronic atrial fibrillation are not excluded)

View trial on ClinicalTrials.gov

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